Self-assembling Peptide With Sodium Fluoride in Treating White Spot Lesionss in Primary Teeth

Not Applicable

Completed

• Conditions: White Spot Lesion
• Interventions: Other: Fluoride varnish (DURAFLOR; Other: Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR

• Registration Number: NCT05721586
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimally invasive therapy using Self-Assembling Peptide P11-4 (CURODONTTM REPAIR) which enhances remineralization of white spot lesions (WSLs). The study aimed to assess clinically the effect of Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR) versus a 5% fluoride varnish (DURAFLOR) on remineralization of enamel White Spot Lesions in primary teeth.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Status Verified: 2023-02
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Study First Posted: 2023-02-10
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• children with high caries risk with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1, 2 or 3

Exclusion Criteria

• Children with systemic diseases
• Teeth with cavitated lesion involving dentin and enamel defects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoride Varnish (DURAFLOR) only	Fluoride varnish (DURAFLOR	-
CURODONTTM REPAIR: + Fluoride varnish (DURAFLOR)	Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR	-

Primary Outcome Measures

Name	Time	Method
Change in DIAGNOdent readings	Baseline, 3 months, and 6 months	The measurements with the DIAGNOdent device that provides numerical values from 0 to 99

Secondary Outcome Measures

Name	Time	Method
Change in ICDAS II scores	Baseline, 3 months, and 6 months	Code 0 Sound tooth surface: Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel visible when wet, lesion must be visible when dry.; Code 3: Localized enamel breakdown because of caries with no visible dentin or underlying shadow.; Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown.; Code 5: Distinct cavity with visible dentin. Code 6: Extensive distinct cavity with visible dentin. After treatment, the evaluation will be performed as follows.
Change in Nyvad scores	Baseline, 3 months, and 6 months	Code 0: Sound - Normal enamel; Code 1: Active caries (intact surface) - Surface of enamel is whitish/yellowish opaque; Code 2: Active caries (surface discontinuity); Code 3: Active caries (cavity) - Enamel/dentin cavity easily visible with the naked eye.; Code 4: Inactive caries (intact surface) - Surface of enamel is whitish, brownish or black.; Code 5: Inactive caries (surface discontinuity) - Same criteria as score 4. Localized surface defect (microcavity) in enamel only Code 6: Inactive caries (cavity) - Enamel/dentin cavity easily visible with the naked eye; surface of cavity may be shiny and feels hard on probing with gentle pressure.

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt